Safety evaluation for quasi-drug use at HIFU treatment site for the facial sagging - Safety evaluation for quasi-drug use at HIFU treatment site for the facial sagging

POLA Chemical Industries,Inc.0 sites24 target enrollmentNovember 9, 2023

ConditionsSagging

Overview

Phase: 未知
Intervention: Not specified
Conditions: Sagging
Sponsor: POLA Chemical Industries,Inc.
Enrollment: 24
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 9, 2023

End Date

August 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

POLA Chemical Industries,Inc.

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•(1\) Persons who have skin symptoms such as external wound, acne, eczema, etc. on the face (from the eyebrows to the chin) (2\) Persons who have a history of surgery or injections (filler or metal) on the face (from eyebrows to chin tip) (3\) Persons who have undergone cosmetic surgery in the past and are currently in the downtime period (4\) Persons who have experienced severe pain, erythema, or scarring after undergoing cosmetic surgery in the past (5\) Persons who have undergone cosmetic medical surgery (laser irradiation, photofacial, injection therapy, HIFU, incision, thread lift, etc.) that affect the shape and/or color tone of the face (6\) Persons with a history of atopic dermatitis (7\) Persons with allergies to disinfectant alcohol and/or rubber (8\) Persons who are taking medicines (anticoagulants, etc.) that may affect the HIFU treatment (9\) Persons who are pregnant, lactating, or planning to become pregnant during the study period (10\) Persons who drink alcohol excessively on a regular basis (11\) Persons who regularly go or plan to go to tanning salons or plan to do so during the study period (12\) Persons who are expected to suffer from severe hay fever\* during the study period (\*level requiring a hospital visit) (13\) Persons who are likely to be exposed to significant sunlight during the study period (e.g., Daily exercise during the daytime) (14\) Persons with a history of serious hepatic disorder, renal disorder, or myocardial infarction (15\) Persons with severe anemia (\* Persons who have been to the hospital multiple times in the past due to anemia) (16\) Persons receiving hormone replacement therapy (17\) Persons who are currently participating in another clinical study or will participate in another clinical study during the study period (18\) Persons with fever (\*Exclusion criteria only on the day of the visit. Temperature will be taken at the reception desk) (19\) Other persons deemed inappropriate by the research physician